Establishing a validation process is part of the price of staying in business, according to Brian Callahan, president of EEC & Associates (Middletown, MA). As a critical part of the quality system, validation also plays a role in the inspection process. Callahan encouraged attendees at MD&M West to set up a master plan that provides the basis for their firm's validation method.
Testing a System
Callahan broke the validation system down into four testable areas:
• Installation qualification performed on all process equipment ensures that it meets manufacturer specifications.
• Operational qualification defines the functioning bounds for equipment. It involves running equipment and making certain that a process meets defined requirements based on a product's intended use.
• Performance qualification determines that a process consistently manufactures a product that meets the requirements.
• Process validation is performed when subsequent inspection and testing cannot completely verify process results.
A validation master plan identifies company rationales, activities, objectives, and responsibilities. Although such a plan isn't specified in FDA regulations, the agency regards it as a CGMP, said Callahan. It should be referred to and updated whenever design changes are made in a process or product. He advised firms to start writing one as soon as possible to avoid mistakes and to keep all employees in the loop.
FDA is supposed to inspect manufacturers of Class II and III devices at least once every two years. The agency cannot even meet its own internal requirements. However, when FDA comes knocking, a company's first line of defense should be a validation master plan. The plan will keep FDA from going on a “hunting expedition,” said Callahan.